The New EMC Directive 2004/108/EC and the DTI transposition

2. The New EMC Directive 2004/108/EC and the DTI transposition Brian Jones and Peter Howick

3. SCOPE • 2004/108/EC regulates the EMC of equipment • Apparatus • Finished appliance (or combination thereof) intended for the end user and made commercially available as a single functional unit • Components or sub-assemblies intended for an end user to incorporate into apparatus (“direct function” no longer relevant) • Mobile installations (combinations of apparatus and other devices) intended to be moved and operated in a range of locations • Fixed installations • Particular combination of several types of apparatus and other devices • Assembled, installed, and intended for permanent use at a predefined location • Different regulatory requirements

4. ESSENTIAL REQUIREMENTS • Protection requirements for all equipment • Designed and manufactured having regard to the state of the art • Emission unchanged • Immunity “without unacceptable degradation” in the presence of disturbances to be expected in intended use • Fixed installations have specific requirements • To be installed • Applying good engineering practices • Respecting the information on the intended use of components • With a view to meeting the protection requirements • Good engineering practices must be documented • Documentation to be held by responsible person(s) as long as the installation is in operation

5. CONFORMITY ASSESSMENT • Required for apparatus only • Not required for apparatus for a given fixed installation not otherwise commercially available • Competent Bodies become Notified Bodies • Purpose and criteria for appointment similar • Notified Body involvement voluntary in all circumstances • Routes to compliance simplified • Internal production control (Annex II) or with Notified Body (+ Annex III) • EMC assessment or correct application of all relevant harmonised standards • Technical documentation • Evidence of conformity drawn up by manufacturer (design and manufacture) • Must allow conformity with essential requirements to be assessed • Manufacture must be in accordance with the technical documentation

6. DECLARATION OF CONFORMITY • Additional requirements • A reference to the new EMCD 2004/108/EC • Identification of the apparatus by type, batch, serial numbers, etc. • Name and address of the manufacturer • Name and address of authorised representative (if applicable) • Dated references to the specifications under which conformity is declared • Date of the declaration • Identity and signature of the person empowered to make the declaration

7. INFORMATION REQUIREMENTS • New requirements for information to be supplied with each apparatus • Identification by type, batch, serial number • Name and address of the manufacturer • Name and address of authorised representative or responsible person • Where the manufacturer is not established in the Community • Instructions for use • To enable use in accordance with the intended purpose • Specific precautions to be taken • To ensure conformity with the protection requirements • Covering assembly, installation, use and maintenance • A clear indication of restriction of use • Where compliance is not ensured in residential areas

8. FIXED INSTALLATIONS • “Responsible person(s)” are responsible for conformity • Member States will set out provisions for their identification • Where there are indications of non-compliance • Such as complaints of interference • Authorities may • Request evidence of compliance • Initiate and assessment, where appropriate • Where non-compliance is established • Authorities may impose appropriate measures to bring the installation into compliance with the protection requirements

9. APPARATUS FOR FIXED INSTALLATIONS • Apparatus for a given fixed installation (only) need not • Meet the essential requirements • Undergo a conformity assessment • Be CE marked • Meet all information requirements • But must • Be identified, and carry the manufacturer’s name and address • Be accompanied by documentation that • Identifies the fixed installation into which the apparatus will be installed • Identifies the electromagnetic compatibility characteristics of the installation • Indicates the precautions to be taken for incorporation so as not to compromise the installation’s conformity

10. TRANSPOSING THE EMC DIRECTIVE • Overall Government policy on transposition is to achieve the objectives of the European measure, on time and in accordance with other UK policy goals, while minimising the burdens on business. • Transposition does not stand on its own, but is an integral part of process that begins with the Commission proposal, moves through the negotiation phase, and culminates in the transposition phase which ends with the implementing regulations being laid before Parliament. • At every stage there is a need to keep ministers and Parliament informed. • Final Text appears in Official Journal (31 Dec 2004)

11. WHAT DOES DTI HAVE TO DO TO TRANSPOSE EMCD? (1) • Process subject to Cabinet Office rules. • Regulations are drafted in a way which is “simple, transparent and easily understood”. Policy is now to use “copy-out” rather than “elaboration”. Beware of “Gold-Plating”! • DTI must produce a Regulatory Impact Assessment (RIA) of the economic effect of the new regulations. • DTI issue a formal consultation document, including the draft regulations, RIA (and possibly guidance on particular issues) giving stakeholders a three-month period in which to comment.

12. WHAT DOES DTI HAVE TO DO TO TRANSPOSE THE EMCD? (2) • DTI give feedback on responses to consultation and show how it influenced the proposed transposition. (There may also be a short second consultation if substantial changes need to be proposed following first one.) • DTI prepare Transposition Note - a memorandum required by Parliament for any legislation giving effect to European Directives, which describes how the Government proposes to transpose the main elements of the Directive into UK law. • Produce UK guidance that explains the regulations in non-legal terms. (There will also be EU guidance.)

13. EMC DIRECTIVE: TIMETABLE FOR UK TRANSPOSITION (1) • New EMC Regulations now being drafted with DTI Lawyers. • Regulatory impact assessment already prepared. • Consultation document to be drafted between January and March 2006 • Consultation to be published end of March 2006 • Possibility that UK guidance on particular issues may be published with the consultation document. (Full guidance later.)

14. EMC DIRECTIVE: TIMETABLE FOR UK TRANSPOSITION (2) • (Possible) second consultation document to be issued by end of August 2006. • Second consultation would have to be completed by end of September 2006 latest. • Signed Statutory Instrument (SI) to be laid in Parliament by early December 2006. • SI to come into force by 20 January 2007. • SI to be applied from 20 July 2007 (But SoS may need powers to appoint Notified Bodies earlier).